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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device trocar
Product CodeDRC
Regulation Number 870.1390
Device Class 2


Premarket Reviews
ManufacturerDecision
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 5
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 62 62
2017 70 70
2018 85 85
2019 95 95
2020 108 108
2021 78 78
2022 60 60
2023 109 109
2024 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 452 452
Break 79 79
Activation, Positioning or Separation Problem 29 29
Difficult to Insert 23 23
Fracture 12 12
Insufficient Information 11 11
Detachment of Device or Device Component 10 10
Gas/Air Leak 10 10
Unintended Movement 9 9
Material Separation 8 8
Contamination /Decontamination Problem 5 5
Device Contamination with Chemical or Other Material 5 5
Use of Device Problem 5 5
Material Fragmentation 4 4
Bent 4 4
Difficult to Advance 4 4
Appropriate Term/Code Not Available 4 4
Physical Resistance/Sticking 4 4
Patient Device Interaction Problem 3 3
No Apparent Adverse Event 3 3
Positioning Problem 3 3
Material Twisted/Bent 3 3
Corroded 3 3
Leak/Splash 2 2
Loose or Intermittent Connection 2 2
Detachment Of Device Component 2 2
Difficult to Remove 2 2
Failure to Advance 2 2
Improper or Incorrect Procedure or Method 2 2
Component Missing 2 2
Device Contamination with Body Fluid 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Contaminated During Manufacture or Shipping 2 2
Material Protrusion/Extrusion 2 2
Defective Device 2 2
Device Operates Differently Than Expected 2 2
Scratched Material 2 2
Component Misassembled 1 1
Noise, Audible 1 1
Device-Device Incompatibility 1 1
Device Or Device Fragments Location Unknown 1 1
Malposition of Device 1 1
Inadequacy of Device Shape and/or Size 1 1
Compatibility Problem 1 1
Dull, Blunt 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Expiration Date Error 1 1
Failure to Disconnect 1 1
Physical Resistance 1 1
Material Rupture 1 1
Inflation Problem 1 1
Contamination 1 1
Complete Blockage 1 1
Partial Blockage 1 1
Loss of or Failure to Bond 1 1
Air Leak 1 1
Failure To Adhere Or Bond 1 1
Mechanical Problem 1 1
Delivered as Unsterile Product 1 1
Unintended Collision 1 1
Particulates 1 1
Crack 1 1
Positioning Failure 1 1
Entrapment of Device 1 1
Flaked 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cardiac Perforation 359 359
No Clinical Signs, Symptoms or Conditions 74 74
No Known Impact Or Consequence To Patient 69 69
Pericardial Effusion 50 50
No Consequences Or Impact To Patient 28 28
Cardiac Tamponade 27 27
Death 20 20
Low Blood Pressure/ Hypotension 19 19
Stroke/CVA 14 14
Perforation 12 12
No Patient Involvement 11 11
Great Vessel Perforation 9 9
Foreign Body In Patient 7 7
Thrombosis/Thrombus 6 6
No Code Available 6 6
Cardiac Arrest 6 6
Hemorrhage/Bleeding 6 6
Arrhythmia 5 5
Insufficient Information 5 5
Vascular Dissection 5 5
Device Embedded In Tissue or Plaque 4 4
Air Embolism 4 4
Transient Ischemic Attack 4 4
Hematoma 3 3
Needle Stick/Puncture 3 3
No Information 3 3
Patient Problem/Medical Problem 3 3
Pseudoaneurysm 3 3
Thrombus 2 2
Perforation of Vessels 2 2
Aortic Dissection 2 2
Pain 2 2
Hemothorax 2 2
Embolus 2 2
Extravasation 1 1
Fistula 1 1
Hypersensitivity/Allergic reaction 1 1
Hypoxia 1 1
Myocardial Infarction 1 1
Occlusion 1 1
Atrial Fibrillation 1 1
Bradycardia 1 1
Chest Pain 1 1
Non specific EKG/ECG Changes 1 1
Edema 1 1
Ventricular Fibrillation 1 1
Pneumothorax 1 1
Pulmonary Edema 1 1
ST Segment Elevation 1 1
Sudden Cardiac Death 1 1
Atrial Perforation 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Blood Loss 1 1
Superficial (First Degree) Burn 1 1
Unspecified Vascular Problem 1 1
Asystole 1 1
Unspecified Tissue Injury 1 1
Foreign Body Embolism 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II Nov-13-2021
2 Cook Inc. I Mar-13-2019
3 Cook Incorporated II Apr-12-2024
4 CooperSurgical, Inc. II May-01-2018
5 Merit Medical Systems, Inc. II Mar-16-2021
6 Merit Medical Systems, Inc. II Apr-12-2016
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